December 19, 2007

Congress has approved the final 2008 budget appropriations in an omnibus bill that, combined with the Defense Department appropriations bill enacted earlier, provides only approximately one percent more funding for basic and applied research than federal agencies were budgeted in 2007, according to American Association for the Advancement of Science analysis.

On December 19, Congress approved the omnibus bill that includes the remaining 11 of the 12 appropriations to fund federal agencies for fiscal year 2008. The bill now goes to President Bush for signature. The federal fiscal year began on October 1.

In November, a separate appropriations bill for Defense Department spending was approved. That bill included a controversial provision to cap overhead on DOD-funded basic research grants and contracts at 35 percent.

December 13, 2007

The federal Office of Management and Budget is consolidating and replacing four existing financial reporting forms (SF–269, SF–269A, SF–272, and SF–272A) with a single new Federal Financial Report (FFR), to give recipients of grants and cooperative agreements a standard format for reporting the financial status of their awards.

OMB published a final request for comments in the December 7 Federal Register on the new Federal Financial Report, including a copy of the proposed form (beginning on the 14th page of the PDF). Comments are due to OMB by January 7, 2008.

The announcement states that the “FFR standardizes reporting information by providing a pool of data elements from which agencies can choose to use for reporting purposes.” Federal agencies will not be not required to collect all of the information included in the FFR. Instead, agencies will identify, before or at the time the award is made, the data elements that recipients must complete, the reporting frequency, the periods covered by each report, report due dates, and where reports are to be submitted.

November 30, 2007

The National Institutes of Health has announced that the “error correction window” will be reduced from five business days to two business days for all electronically submitted grant applications with submission deadlines on or after January 8, 2008. The “error correction window” is the the time allowed after the submission deadline to address NIH system-identified errors and warnings. The two business days provided to view the assembled application image in eRA Commons will remain unchanged.

This change will mean that electronic applications will be considered “on-time” if all of the following criteria are met:

All required registrations must be complete prior to the initial submission.

Initial successful submission to Grants.gov must have a timestamp on/before 5:00 p.m. local time of the applicant organization on the receipt date.

Applicants must correct errors and/or warnings within the two business days following the receipt date.

All application corrections must be in response to a system-identified error/warning; application submissions with additional changes may be refused.

If final submission is sent after the receipt date, a cover letter attachment must be included identifying the system-identified errors and warnings that have been corrected.

November 20, 2007

Grants.gov is continuing work on replacing PureEdge Viewer application packages with Adobe Forms. However, most Grants.gov application packages are still in PureEdge format. The National Institutes of Health, for example, will use PureEdge forms at least through March 2008.

Investigators and staff considering upgrading to new Mac or Windows operating systems need to be aware of compatibility issues with PureEdge forms.

Macintosh - PureEdge Special Edition Mac Viewer does not work with Mac OS X Leopard. To submit Grants.gov PureEdge forms on a Macintosh computer, either stay at OS X 10.4.6, use a virtualization product, install emulator software, or use a Windows terminal service. See Grants.gov “Apply” at Berkeley for more information on PureEdge on the Mac.

For information and news on the transition to Adobe Forms, see the Grants.gov Program Status and Help pages, and Grants.gov “Apply” at Berkeley. Grants.gov now supports the latest version of Adobe Reader (8.1.1) and continues to support Adobe Reader version 7.0.9.

November 14, 2007

Thinking Outside the Box: Addressing the Challenges of Human Subject Research in 2008Co-sponsored by University of California Davis and OHRPDoubletree Hotel, Sacramento, CAFriday, February 8, 2008http://www.research.ucdavis.edu/ohrpconference

The Office for Human Research Protections (OHRP) in conjunction with the University of California Davis will be sponsoring a National Research Community Forum entitled, “Thinking Outside the Box: Addressing the Challenges of Human Subject Research in 2008,” on Friday, February 8, 2008, at the Doubletree Hotel in Sacramento California. Co-sponsors for this forum are the Northern California IRB Consortium Forum, the California State University Chancellor's Office, California State University Long Beach, the San Jose State University, and the California State University San Marcos.

This forum will focus on specific applications and interpretations of the regulations entitled, “Protecting Human Subjects” for conducting biomedical and behavioral research that is funded by the Department of Health and Human Services. The program will showcase experts from academia and the federal and state governments who will address unique aspects for balancing the principles of The Belmont Report in conjunction with federal and state laws and ensuring that the protection of human subjects in clinical trials is maximized. Representatives from the OHRP, U.S. Food and Drug Administration, National Institutes of Health, Department of Education, and the Department of Defense will provide federal regulatory updates and clarification of key policy issues.

This forum should be of special interest to those persons currently serving or about to begin serving as a member of an IRB as well as institutional officials and administrators, principal investigators, legal counsel, research staff, patient advocates, research sponsors, public health officials, privacy officials, compliance officers, laypersons and sponsors and contract research professionals.

November 13, 2007

The Research Administration and Compliance Information Systems team (RAC-IS) is making final preparations to switch to the new, upgraded Berkeley Coeus version 4 in late November. The Berkeley Coeus system is the institutional system of record for tracking all Berkeley campus research proposals and awards processed by the Sponsored Projects Office (SPO) and the Industry Alliances Office (IAO). Data captured in Coeus is passed automatically to the Berkeley Financial System (BFS) to establish and modify fund accounts for project spending.

RAC-IS is working to make the transition to Coeus 4 as transparent and smooth as possible for the campus. However, during the move to the new system, Coeus may be unavailable for one to two days. The interruption in service will affect the Coeus to BFS feed for award set up as well as access to Coeus Web. Campus staff and faculty with possible issues related to award setup during this period may contact Kevin Phung (kphung@berkeley.edu). RAC-IS will provide more details on the move to Coeus 4 during the next several weeks.

The upgrade is a complete technical migration. The client application is now written in Java; upgrades from MIT will be incorporated as they are released, while at the same time preserving Berkeley customizations; the entire system will run on Campus Data Center Web Farm and database infrastructure; and all legacy data will be migrated to the new system. Benefits out of the box include enhanced capabilities for documenting proposal reviews, tracking agreement negotiations, managing subcontracts and subcontractors, and compliance information, among others.

The upgrade project lays the groundwork for future enhancements in a number of areas, including reporting and campus access to SPO data, conflict of interest disclosure tracking, routing and approval of proposals through the campus, and system-to-system submission of fully electronic proposals to the federal Grants.gov system. When implemented, the new human and animal subjects protocol systems will be integrated with Coeus.

The National Science Foundation, on behalf of the federal Chief Financial Officers Council’s Grants Policy Committee, the Grants.gov Executive Board, and the National Science and Technology Council’s Research Business Models Subcommittee, is soliciting public comment on a standardized format for Research Performance Progress Reports (RPPR).

The objective of the initiative is to establish a uniform format for reporting performance on federally funded research projects. The proposed format is for interim progress reports only. A similar format may be considered for final reports after this RPPR initiative.

Proposals with deadlines during the campus shutdown should arrive at SPO by Friday, December 7, 2007.

Proposals due at agencies in early January should be at SPO before Friday, December 14, 2007.

ACUC Protocol Submission

The deadline for protocol submission for the December 5, 2007 meeting is Monday, October 22, 2007.

The deadline for protocol submission for the January 23, 2008 meeting is Monday, December 10, 2007.

CPHS Protocol Submission

The deadline for protocol submission for the December 7, 2007 CPHS-I meeting is Monday, November 5, 2007.

The deadline for protocol submission for the December 14, 2007 CPHS-II meeting is Monday, November 12, 2007.

The deadline for protocol submission for the January 4, 2008 CPHS-I meeting is Monday, December 3, 2007.

The deadline for protocol submission for the January 18, 2008 CPHS-II meeting is Monday, December 10, 2007.

Please note that if your study was given full board review last January and approval will expire before January 4, 2008, you must submit your renewal application in time for review at a December 2007 CPHS meeting.

October 24, 2007

Sponsored Projects Office staff recently received a reminder from the U.S. Department of Energy that Protected Personally Identifiable Information (PII) is not to be included in any technical report submitted to DOE. DOE has noticed that some scientific and technical reports submitted by award recipients using the DOE Energy Link System has had Protected PII included.

If you have already submitted a report to DOE containing Protected PII, DOE asks that you contact your DOE contracting officer immediately. Technical reports submitted to the DOE Energy Link System that were marked as publicly releasable “unlimited announcement” will be made public through DOE public web systems.

PII is any information about an individual which can be used to distinguish or trace an individual’s identity. Some information that is considered to be PII is available in public sources such as telephone books, public websites, university listings, etc. This type of information is considered to be Public PII and includes, for example, first and last name, address, work telephone number, email address, home telephone number, and general educational credentials.

In contrast, Protected PII is defined as an individual’s first name or first initial and last name in combination with any one or more of types of information, including, but not limited to, social security number, passport number, credit card numbers, clearances, bank numbers, biometrics, date and place of birth, mother’s maiden name, criminal, medical and financial records, educational transcripts, etc.

October 11, 2007

When preparing a proposal to submit to Grants.gov or other electronic submission systems, please take the time to make sure files aren't larger than they need to be. Grants.gov does not currently have a limit set for file size. However, large files can fill up email quotas, take more time to upload, and slow down computer performance. These problems are compounded near deadlines when staff are working with multiple proposals at the same time.

For an example of what can go wrong, the Sponsored Projects Office had a recent Grants.gov experience in which a SPO staff member was trying to replace a budget on a PureEdge file that was very large because of the number of scanned PDF attachments. Trying to work with this large file caused the SPO computer to hang, which resulted in wiping out all the information in the PureEdge file. Fortunately, SPO had a backup copy of the file. SPO technical staff worked to reduce the size of this file by optimizing the PDF attachments, then the SPO research administrator was able to upload the revised file in time to meet the Grants.gov deadline that afternoon.

For an example of what is considered large, the National Institutes of Health expects an average R01 application to be in the six to 10 megabyte (MB) range with 99 percent of applications falling under 40 MB. NIH provides guidance on file size in the NIH Frequently Asked Questions on electronic submission. One basic tip from NIH is to avoid scanning text documents to produce PDFs. Instead, NIH recommends producing the documents electronically using text or word-processing software and then converting documents to PDF, and making scanned documents the exception rather than the rule when preparing an application.

What You Can Do• Start Early and Ask for HelpPlease start working on your application early, especially if you are using Grants.gov for the first time. If you are new to Grants.gov, preparing applications for electronic submission, or need help with the process, contact SPO staff early.

• ScanningWhen scanning documents is necessary, for example when collaboration letters need to be included with the proposal, set the scanner at 150 dpi (dots per inch) instead of a higher resolution. In some cases, an even lower resolution, such as 72 dpi, might work without sacrificing readability.

• ImagesWhen preparing images to include in a PDF, reduce the size or resolution in an imaging editing program and use compression such as JPEG to save images. Please note that when experimenting with resolution, make sure the results are suitable before making changes that can't be undone.

Computer System RequirementsIf you are still having trouble working with files even when reducing size whenever possible, you might need a more powerful computer. Grants.gov provides the minimum requirements for PureEdge, but depending on the file types and applications you work with to create the final PureEdge file, this configuration may be inadequate. Grants.gov states that for PureEdge Viewer to function properly, your computer must meet the following system requirements: Windows 98, ME, NT 4.0, 2000, XP; 500 MHz processor; 128 MB of RAM; 40 MB disk space; Web browser: Internet Explorer 5.01 or higher, Netscape Communicator 4.5 - 4.8, Netscape 6.1, 6.2, or 7. SPO desktop machines have a 2 GHz processor, 1 GB RAM, and an 80-160 GB disk.

IBM has provided Special Edition Mac Viewers for PPC and Intel running Macintosh OS 10.4 or higher that are available for download. If that solution does not work and if you do not have a Windows operating system, you will need to use a Windows Emulation program. SPO provides more information on using Grants.gov with a Macintosh computer.

October 05, 2007

The 2008 federal fiscal year (FY) began on October 1, 2007. However, Congress did not finish any of the appropriations bills that would give federal agencies their budgets. Instead, Congress passed a “continuing resolution,” or temporary appropriations bill, that extends funding at 2007 levels through November 16, 2007. In previous years, Congress has issued more than one continuing resolution when more time was needed to finish the budget appropriations. Last year, for example, the FY 2007 federal budget was not passed until February 2007.

The National Institutes of Health issued guidance on Non-Competing Grant Awards Under the Current Continuing Resolution in the October 5 NIH Guide, stating:“Until the final FY 2008 appropriation is enacted, NIH will issue non-competing research grant awards at a level below that indicated on the most recent Notice of Award (generally up to 80% of the previously committed level). This is consistent with our practice during the CRs of FY 2006 & 2007. NIH will consider upward adjustments to these levels after the final appropriation is enacted, but expects institutions to monitor their expenditures carefully during this period.”

The Susan G. Komen for the Cure foundation has a new electronic application submission system. Because this is a new, untested system, it is critical that researchers submit one printed copy of the full application with a signed Proposal Review Form to the Sponsored Projects Office at least five working days before the Komen deadline. If the application is not received at SPO five working days before the deadline, SPO cannot guarantee review and successful submission of the application. The UC Berkeley policy on electronic proposal submission is available on CalMessages. Please note that the preferred deadline to SPO is 10 working days before the agency deadline to allow time for thorough review.

October 01, 2007

The National Institutes of Health has published the September edition of NIH Extramual Nexus. The articles, linked below, include interviews, news, and updates from the agency.

For those planning on applying for NIH grants in the near future, a Use of Adobe Forms article explains that NIH will continue to use PureEdge forms at least through March 2008 grant application submission deadlines. A related article, Future Electronic Submission Transitions Still on Hold, states that the transition of NIH Training Grants (T), Career Development Awards (K), and Fellowships (F) to electronic application submission will not occur until Grants.gov can develop the new Adobe forms.

September 27, 2007

The National Science Foundation has published Important Notice No. 130: Transformative Research. The Important Notice outlines the NSF implementation of the National Science Board motion to enhance support of transformative research at NSF. The document is available at http://www.nsf.gov/publications/pub_summ.jsp?ods_key=in130.

The Notice highlights the change to the NSF Intellectual Merit Review Criterion to specifically include review of the extent to which a proposal also suggests and explores potentially transformative concepts. The full text of the newly revised Criterion is:

What is the intellectual merit of the proposed activity?How important is the proposed activity to advancing knowledge and understanding within its own field or across different fields? How well qualified is the proposer (individual or team) to conduct the project? (If appropriate, the reviewer will comment on the quality of prior work.) To what extent does the proposed activity suggest and explore creative, original, or potentially transformative concepts? How well conceived and organized is the proposed activity? Is there sufficient access to resources?

Effective October 1, 2007, the Grant Proposal Guide and new funding opportunities issued after this date will incorporate the change to the Intellectual Merit Criterion. Proposals received after January 5, 2008, will be subject to the revised Merit Review Criterion.

October 1, 2007 Update: NSF Revises PAPPG to Include New CriterionNSF has published a revised version of the NSF Proposal & Award Policies & Procedures Guide (PAPPG), NSF 08-1. The revisions were made only to the Grant Proposal Guide (GPG); all other parts of the PAPPG remain unchanged. The significant changes made to the GPG include the revision of the intellectual merit review criterion to specifically include language on potentially transformative research, updated guidance on the designated fonts that may be used when preparing an NSF proposal, and the requirement that organizations must be registered in the Central Contractor Registration prior to submitting a proposal to NSF. NSF notes that while the changes are effective for proposals submitted on or after January 5, 2008, proposers are strongly encouraged to begin complying with the guidance as soon as possible.

September 21, 2007

The first step in obtaining funding to support research and other projects is often a search for programs that might support the project. The campus subscribes to two funding databases that can make identifying potential funding sources a manageable prospect, and the Sponsored Projects Office provides assistance with searches and other resources to help in the task.

Funding Databases

The Berkeley campus subscribes to the Community of Science (COS) and IRIS funding opportunities databases; each is accessible on any computer with a berkeley.edu address. COS and IRIS can be used to search or browse program announcements in all areas from federal and regional government sponsors, foundations, and other organizations. The program listings provide full information on each funding opportunity and links to the agency program announcements.

If you are new to using IRIS or COS, the best way to start may be to use the keyword search to select one or more areas of interest, then browse the search results. If the results are too extensive, narrow the search by adding a qualifier or two. The IRIS Help File and COS Instructions are recommended reading for search tips and guidance.

IRIS also provides listings of programs with upcoming deadlines in over twenty subject areas. The lists are divided into two groups: one for all academic levels, and the other for graduate students and undergraduates.

For help using the COS and IRIS databases or for an individual funding search for Berkeley faculty, contact Shelley Sprandel at spore@berkeley.edu or 2-8122.

Other SPO Resources

The SPO web site has additional resources on funding program information. The funding page provides the following:

August 21, 2007

In recent years, the funding rate for National Science Foundation proposals has decreased, while NSF budget, average award size, and proposal submission rates have increased. The percentage of principal investigators that are funded has decreased, as the number of PIs submitting to NSF has increased.

Responding to concerns that this trend may be having negative impacts on the academic research community, NSF established the Impact of Proposal and Award Management Mechanisms Working Group (IPAMM) in March 2006. IPAMM was charged to “recommend policies and preferred practices to improve NSF’s program announcement and solicitation processes in ways that achieve appropriate balances between proposal funding rates, award sizes and award duration in the various types of awards that comprise the total NSF portfolio, with the emphasis on individual, investigator-initiated grants.”

1. NSF should require that each of the directorates and research offices develop an overarching strategic framework, incorporating flexible management approaches.

2. Long-term planning for accommodating growth in the communities and infrastructure built by research investments (including both physical infrastructure and human resources) must be incorporated when developing new funding opportunities.

3. The practice of limiting the number of proposals that a principal investigator or institution may submit is appropriate in some situations but should be considered in the context of relevant trade-offs and impacts on the community.

4. Careful consideration should be given to the short-term use of various management practices to increase the number of awards and reduce the need to revise and resubmit highly rated proposals.

5. NSF management should inform the appropriate internal and external communities when implementing new proposal management practices and should monitor their concerns during implementation.

6. NSF should ensure that the community has access to specific and accurate statistical data on funding rates; this will include evaluating the Budget Internet Information System and updating it, as needed.

7. NSF should annually update trend analyses for internal review, and include it in the annual Report on the NSF Merit Review Process to the Board.

August 20, 2007

The America COMPETES Act (America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science Act), H.R. 2272, was signed into law by the President on August 9, 2007. The Act, passed by both chambers of Congress just before the August recess, is the legislative response to the recommendations contained in the National Academies Rising Above the Gathering Storm report. The Act authorizes various programs at the National Science Foundation and the Departments of Energy, Commerce, and Education intended to strengthen education and research in the United States related to science, technology, engineering, and mathematics (STEM).

The Act provides over $40 billion total for fiscal years 2008 to 2010 for STEM programs across federal agencies. Some highlights of the package include:

$22 billion for the National Science Foundation, putting NSF on a path to double in budget approximately seven years, increasing support for a variety of programs including the Integrative Graduate Education and Research Traineeship (IGERT) program, CAREER grants for young faculty, and a new program of seed grants.

Nearly $17 billion for Energy Department programs, keeping the Office of Science on a seven-year doubling path, and establishing an Advanced Research Projects Agency (ARPA-E), patterned after DARPA, to support high-risk, high-reward research.

A new Technology Innovation Program (TIP) at the National Institute of Standards and Technology, replacing the Advanced Technology Program but allowing university participation.

The National Institutes of Health is undertaking a comprehensive look at the entire NIH system of research support, including the peer review system, in order to enhance its efficiency and effectiveness, and is inviting public participation in the discussion. Written comments are requested by September 17. NIH is also holding a series of regional meetings to discuss enhancing peer review:

September 12, 2007 – Chicago

October 8, 2007 – New York City

October 25, 2007 – San Francisco

The October 25 meeting will be held from 9:00 a.m. until 1:00 p.m at the Parc 55 Hotel, near 5th and Market in downtown San Francisco. To attend, please register online.

Meeting context and review of ongoing activities Dr. Lawrence TabakDirector, National Institute of Dental and Craniofacial Research, NIHCo-Chair of the Working Group of the Advisory Committee to the NIH Director (ACD) on NIH Peer Review

9:15–9:30

Goals for the meeting Dr. Keith YamamotoExecutive Vice Dean, School of Medicine, UCSFProfessor, Cellular/Molecular Pharmacology and Biochemistry/Biophysics, UCSFCo-Chair of the Working Group of the Advisory Committee to the NIH Director (ACD) on NIH Peer Review

9:30–10:30

Statements/proposals from External Scientific Community offering specific strategies or tactics for enhancing NIH peer review and research support

10:30–10:45

Break

10:45–11:45

Open discussion: Response to emerging themesAs part of our iterative process we welcome feedback about a series of issues/suggestions that have been made thus far- these will be posted on the website in advance of the meeting Drs. Yamamoto and Tabak, Facilitators

11:45–12:45

Open Discussion 1) Challenges and opportunities for NIH system of research support 2) Challenges and opportunities for NIH peer reviewDrs. Yamamoto and Tabak, Facilitators

August 06, 2007

The Research Administration and Compliance Office is very pleased to report that work has begun on the “eProtocol” Project to implement an online protocol management system to support research projects involving human or animal subjects. The system is designed to replace manual, paper-based research protocol processes with a broadly distributed electronic system to simplify protocol submission, processing, and compliance monitoring. The Office of the CIO’s Technology Program Office is providing the services of Jon Conhaim who is representing RAC as project manager of the eProtocol Project.

Over the next months, we will be installing, configuring, testing, and performing a fit/gap analysis on the system. As part of this work, we will be interviewing faculty and OPHS, ACUC, and SPO staff to determine precisely how the system fits with our existing processes and what gaps may exist that will require process or system modifications.

We are excited to initiate this important project with outcomes that will benefit the entire campus.

August 02, 2007

The Research Administration and Compliance Office has scheduled the monthly RAC Forum meetings for the coming year. This year, we will be holding the RAC Forum on Wednesdays from 10:30 a.m. until noon. All meetings except for April will be held in the Tilden Room, 5th floor, ASUC Martin Luther King Jr. Student Union building. Please save the following dates:

The campus has a new multi-year Facilities and Administration (indirect cost) rate agreement with the federal government. The agreement, dated July 27, 2007, specifies the F&A rates to be applied to awards from federal and non-federal sponsors. Berkeley's last rate agreement expired on June 30, 2006 and allowed for provisional rates through June 30, 2007. Under the new agreement the rate for on-campus research increases to 53 percent on July 1, 2007 and to 53.5 percent on July 1, 2009. The off-campus research rate will remain at 26 percent. The rates for other sponsored activities will also go up and the Space Sciences Laboratory's special rates will be lowered.

Rates for awards with start dates prior to July 1, 2006 will remain at their current levels for the remaining life of the award, including non-competing budget periods. The new rate schedule applies to new awards (including new competing budget periods) received on or after July 1, 2006. Thus the overhead rate applied to a multi-year on-campus competitive research award received on or after July 1, 2006 will be 52 percent through June 30, 2007, 53 percent from July 1, 2007 through June 30, 2009, and 53.5 percent thereafter.

These rates will be applied automatically by the Controller's Office. For questions concerning how these rates apply to your contracts and grants, contact your representative at the Sponsored Projects Office. For questions on how F&A rates are determined, contact Gregg Carr at gcarr@berkeley.edu or 3-7564.

July 27, 2007

In a July 27 NIH Guide announcement, the National Institutes of Health announced that all Financial Status Reports (FSRs) (domestic and foreign) due on or after October 1, 2007, must be submitted using the electronic FSR system located in the eRA Commons. This includes all initial FSRs being prepared for submission and any revisions being submitted or re-submitted to NIH. The requirement does not affect other federal agencies and how they may handle FSRs.

The eRA Commons web-based FSR system allows participants to view information on currently due and late FSRs as well as submit FSRs electronically to the NIH. Additional resources including a user guide and an online demonstration can be found on the eRA Commons Support Page.

July 26, 2007

The July 19 Grants.gov Stakeholder Meeting webcast included an update on the transition to Adobe Forms for Grants.gov applications. The archived webcast, a very informative summary of questions and comments from the webcast, and a sample Adobe Cover Sheet are available at http://grants.gov/resources/stakeholder_communications.jsp.

No definite date was given for when federal agencies would begin using the new Adobe Forms for applications instead of PureEdge, but it appears likely that most if not all agencies will not be using Adobe until September at the earliest. The National Institutes of Health will not be finalizing plans until the new forms have been thoroughly tested, and once plans are finalized NIH will make every effort to give 60 days notice prior to transitioning any program.

As of July 19, all 147 Grants.gov forms had been converted to Adobe Forms. Both individual forms and form “families” are now being tested, with 60 forms in production. Grants.gov plans to have all 147 forms available for agencies to use on September 6.

Applicants need to be aware that currently Grants.gov Adobe Forms are compatible only with Adobe Reader version 7.0.9. Using Adobe Reader 8.0 or 8.1 may cause the application to fail validation after submission and thus be rejected by Grants.gov. Adobe is working on these incompatibility issues, and is targeting a permanent resolution for the September/October timeframe.

Effective immediately, the indirect cost rate for agreements with Caltrans, the State of California Department of Transportation, is 17.5 percent applied to a modified total direct cost (MTDC) base as defined in OMB Circular A-21. All new budgets prepared for new and existing projects shall include the 17.5 percent MTDC rate. Any questions about this directive should be addressed to Paula Burkhart (pkburkhart@berkeley.edu) or to Jyl Baldwin (jbaldwin@berkeley.edu).

The CPHS follows the P&P in approving, recommending modifications, and in extremely rare cases, suspending or terminating research involving human subjects. UC Berkeley operates within the regulations and guidelines set forth by federal authorities, primarily the Office for Human Research Protections and the Food and Drug Administration, and other bodies such as the International Conference of Harmonisation, all based upon ethical principles elucidated in the Belmont Report. Many of the policies and procedures are derived from these regulations.

The P&P Table of Contents has embedded links to the document sections, making navigation easier. CPHS will post Attachments and Grant-Protocol Review sections soon.

July 16, 2007

The National Science Foundation is leading the effort to establish a Research.gov web portal. Research.gov is a collaborative partnership of federal, research-oriented, grant-making agencies with a shared vision of increasing customer service for applicants and awardees, while streamlining and standardizing processes amongst partner agencies.

Research.gov will be a one-stop web site that will provide a menu of services in a single portal for research institutions and grantees to conduct electronic grants business with federal agencies and to find information about agency policies and upcoming events. The portal will also help federal agencies share grants management best practices as part of the Grants Management Line of Business. The portal is intended to focus on the needs of grantees, provide maximum flexibility to account for differing agency strategies, and allow the best tools to be offered from any research agency.

Services planned for the portal include a tool for grant applicants to check a list of all proposals submitted to Research.gov partner agencies, a tool to submit federal financial reports, a project-reporting tool, and tools to request funds disbursement and payments. The portal would also link to Grants.gov to find grant opportunities and apply for funding, iEdison to report inventions, NSF FastLane, as well as other services and systems.

According to NSF, federal research agencies will sign up to offer services to grantees through these tools, and NSF will recover operations costs through a fee-for-service arrangement. NSF has already successfully conducted an Application Status pilot with the USDA Cooperative State Research, Education, and Extension Service (CSREES), which allows principal investigators to check the status of their USDA CSREES and NSF proposals at one site.

July 12, 2007

The National Institutes of Health is seeking comments from reviewers, applicants, and members of the public on the system used by NIH to support biomedical and behavioral science, including peer review, with the goal of examining the current process to optimize its efficiency and effectiveness. NIH is especially interested in creative suggestions, even if they involve radical changes to the current approach. Ultimately, NIH wants to ensure that the most meritorious science is supported while minimizing bureaucratic burden.

Comments are due by August 17, 2007 September 7, 2007, and may be submitted online.

July 06, 2007

The National Science Board (NSB), the governing body of the National Science Foundation, established a Task Force on Transformative Research in 2004 to better understand NSF policies to solicit, identify, and fund innovative, potentially transformative research. Transformative research is defined as research driven by ideas that have the potential to radically change our understanding of an important existing scientific or engineering concept or lead to the creation of a new paradigm or field of science or engineering.

The NSB recently published a report, Enhancing Support of Transformative Research at the National Science Foundation, that recommends that NSF “enhance its ability to identify and fund transformative research” and develop a new Transformative Research Initiative “distinguishable by its potential impact on prevailing paradigms and by the potential to create new fields of science, to develop new technologies and open new frontiers.”

The report states that the “Initiative is meant to be only the first step toward achieving a broader and longer-term capacity for supporting revolutionary ideas within NSF and, more importantly, toward providing the freedom that encourages greater boldness of ideas and aspirations within the research community.”

The NSB has asked NSF to report back with a preliminary plan for the Transformative Research Initiative by the August 2007 Board meeting.

June 29, 2007

Effective immediately, the National Institutes of Health, Agency for Healthcare Research and Quality, and National Institute for Occupational Safety and Health have changed the electronic submission of grant applications process to exclude federal holidays from the two weekdays provided for applicants to review their assembled application in the eRA Commons (referred to as the “application viewing window”).

In the past, federal holidays were included in the two weekdays allowed for the application viewing window. Beginning with the July 4, 2007 holiday, federal holidays will be excluded from the two weekday application viewing window and all applications will be held for at least two full, non-holiday weekdays (Monday-Friday).

June 15, 2007

The National Institutes of Health has reviewed the errors and warnings applicants receive in the eRA Commons. As a result of that review and in response to feedback from people using the eRA Commons, NIH is taking steps to improve the process. NIH is making the following changes.

Clarify message text and application guide instructions for the most frequent error and warning messages.

Remove many warning messages (more than 50 percent of the R01 warnings received have been flagged for removal).

Increase system tolerance for minor inconsistencies in names provided in the application when compared to names included in the eRA Commons profile.

When possible, change “errors” to “warnings” to allow the submission to proceed.

Soften the tone of messages and reserve more explicit language or descriptions for cases where delays in application processing are most likely to occur.

Critically examine errors and warnings that are not required for review and could be addressed prior to award.

June 11, 2007

The Air Force Office of Scientific Research, Army Research Office, and Office of Naval Research are soliciting proposals for the fiscal year 2008 Defense University Research Instrumentation Program (DURIP). The DURIP program is “designed to improve the capabilities of U.S. institutions of higher education … to conduct research and to educate scientists and engineers in areas important to national defense, by providing funds for the acquisition of research equipment.”

The program will provide approximately $40 million in FY 2008 to purchase research equipment that costs $50,000 or more. Individual awards will not exceed $1,000,000. In FY 2007, awards ranged from approximately $50,000 to $950,000, averaging $205,000; very few awards exceeded $500,000. Awards are typically one year in length.

AFOSR, ARO, and ONR are also requesting proposals for the FY 2008 Multidisciplinary University Research Initiative (MURI) program. The MURI program supports basic science and/or engineering research at U.S. institutions of higher education that is of critical importance to national defense. The program is focused on multidisciplinary research efforts that intersect more than one traditional science and engineering discipline to address issues of critical concern to the DoD. The FY 2008 MURI competition is for the 19 topics listed in the Broad Agency Announcement.

Total amount of funding for five years is estimated to be about $207 million. It is anticipated that the maximum award will be $1.5 million per year, with the actual amount contingent on availability of funds, the specific topic, and the scope of the proposed work.

The agency program announcements are posted at Grants.gov: ONR, AFOSR, and ARO. Applicants are encouraged to submit white papers (by email or in hard copy) by August 6, 2007, to minimize the labor and cost associated with the production of full proposals that are unlikely to be selected for funding. The deadline for full proposals deadline is October 23, 2007. Proposals may be submitted electronically through Grants.gov or in hard copy.

May 31, 2007

The Research Administration and Compliance Office is pleased to offer a new model for providing news to the campus: the Research Advocate weblog (or blog).

In the new model, news, information, updates, and other content is published dynamically as articles are written. A key feature is news feed technology. By subscribing to the news feed, you can receive new content automatically delivered to your web browser or RSS/Atom reader without your having to visit the site or check e-mail. RAC will continue to e-mail a notice every month with a table of contents linking to each article online.

Other features:

Seven-day rolling list of new awards received by the campus, updated daily.

The Research Advocate weblog includes a syndication feed. By subscribing to the feed, you can receive new content automatically delivered to your web browser or RSS/Atom reader without your having to visit the site or check e-mail.

What are RSS and Atom?RSS (or Really Simple Syndication) and Atom are two types of web feed formats specified in XML (a generic specification for data formats) and used for Web syndication. RSS and Atom delivers information as an XML file called a feed, web feed, RSS stream, or RSS channel. Feeds provide a way for users to easily receive newly released content.

How to SubscribeTo subscribe to a feed, you will need a feed reader or aggregator. Web browsers, email software, and web-based news sites offer a variety of RSS subscription features. You may already have a feed reader built into software you are already using.

Memo - Vice Chancellor for Research Office, University of California, Berkeley - February 7, 2006

Date: 2/7/2006

Sender: Beth Burnside, Vice Chancellor for Research

To: All Academic Titles, Deans, Directors, Department Chairs

Subject: UC Requirement to submit all proposals and to receive all awards for grants and contracts

Since December 1994, it has been University of California policy that all employees who receive any part of their salary through the University, or whose activities use any University resources or facilities, must submit all proposals and receive all awards for extramural support through the appropriate central office, i.e. Sponsored Project Office (SPO) or Industry Alliances Office (IAO). This requirement is necessary to insure that all extramurally funded projects are screened for their compliance with relevant University, state, and federal policies and guidelines, and to insure the appropriate exercise of UCB's fiscal responsibility for all extramural awards.

The purpose of this memorandum is to update and replace the Cerny memorandum of January 3, 1995, implementing the December 15, 1994 UC policy on proposal submission and award acceptance. This policy can be viewed at http://www.spo.berkeley.edu/Policy/grantpolicy.html.

Although this policy remains in effect, there have been an increasing number of cases where faculty have submitted proposals directly to funding sources rather than sending them through SPO or IAO. The authority to implement and carry out the proposal submission policy for the Berkeley campus has been delegated to me as the Vice Chancellor for Research. On behalf of the campus administration, I am writing to strongly reiterate that it is absolutely essential that all UCB faculty and staff comply with UC policy by submitting all grant or contract proposals for extramural funding and accepting all grant or contract awards through SPO or IAO.

Effective immediately, the campus will refuse to accept any grant or contract for extramural funding that has not been appropriately submitted through SPO or IAO. If SPO or IAO receive an award document for a proposal not formally and appropriately submitted through SPO or IAO, the award will be declined. Exceptions may be made only in highly exceptional cases and must be approved in advance and in writing by the Chancellor.

If you have any questions about this memorandum, please contact my office. Thank you, in advance, for protecting Berkeley's research enterprise by helping us make sure that UC, state, and federal requirements are fulfilled.

Memo - Office of the Chancellor, University of California, Berkeley - January 3, 1995

BERKELEY: OFFICE OF THE CHANCELLOR

January 3, 1995

DEANS, DIRECTORS, DEPARTMENT CHAIRS, ADMINISTRATIVE OFFICERS

SUBJECT: Policy on the Requirement to Submit Proposals and to Receive Awards for Grants and Contracts Through the University

This memorandum transmits the new University of California Policy on the Requirement to Submit Proposals and to Receive Awards for Grants and Contracts through the University. This policy is effective immediately.

This new policy states that all employees who receive any part of their salary through the University, or whose activities use any University resources or facilities, must submit their proposals for extramural support through the appropriate local contracts and grants office. Exceptions to this policy may be granted by the Chancellor in unusual circumstances on a case by case basis. If an exception to policy is made, the name of the University shall not be used by the external party under any circumstances.

The authority to implement and carry out this policy for the Berkeley campus has been delegated to me, as the Vice Chancellor for Research. Implementation will begin immediately and will include all currently funded extramural awards, renewals and continuations of current awards, and all new proposals. All currently funded awards must be transferred to the campus if projects involve any effort, salary recovery, use of University resources or facilities, or name the Berkeley campus as the performance site. These transfers must be in process by February 15, 1995. Exceptions will be considered on a case by case basis; however, there will be no blanket exceptions for an organization or individual. Fellowships made directly to a student, post-doctoral fellow, or faculty member will not be affected by this policy.

Any request for exception should be made in writing to the Vice Chancellor for Research, with a copy of the proposal attached. Requests must be reviewed and approved by the appropriate department chair or unit director. Justifications should include a detailed description of the activities to take place outside normal employment and a clear distinction of the difference between service to the University and service to be provided to the external party.

If you have any questions about this new policy or how to request an exemption, please contact Joyce Freedman, Director of the Sponsored Projects Office, at 642-8110.

Joseph Cerny, Vice Chancellor for Research

Memo - Office of the President, University of California - December 15, 1994

University of CaliforniaOffice of the President

December 15, 1994

POLICY ON THE REQUIREMENT TO SUBMIT PROPOSALS AND TO RECEIVE AWARDS FOR GRANTS AND CONTRACTS THROUGH THE UNIVERSITY

It is the policy of the University of California that employees who receive any part of their salary through the University, or whose activities use any University resources or facilities, must submit their proposals for extramural support through the appropriate local contracts and grants office. Awards must be made to The Regents of the University of California.

This requirement is necessary to insure that all research and other extramurally funded projects conducted by University employees, or with the use of University resources or facilities, are approved by the appropriate University contract and grant office and comply with relevant University policies and guidelines, including but not limited to those governing:

- integrity in research;- appropriateness of the activity to the University;- protection of human and animal subjects and the environment;- use of University facilities;- adherence to personnel policies;- compensation plans;- intellectual property;- conflicts of interest;- recovery of direct and indirect costs;- liability insurance and indemnification; and- medical malpractice coverage.

In the case of projects to be conducted by the UniVersity in collaboration with other organizations, the University can be either the prime contractor or a subcontractor. In all cases, all resources required for the conduct of the portion of the work which will be directed by University employees must be included in the award to the University.

Exceptions to the requirement to submit proposals and awards through the University may be granted by Chancellors in unusual circumstances on a case by case basis, after consideration of the policy areas cited above, when it is in the best interest of the University. When an exception is granted, there must be a clear distinction between service to the University and service to the external party; relevant personnel policies shall be followed; the name of the University shall not be used by the external party; and in no case shall the University assume liability for a third party's action without the approval of The Regents as required by the Bylaws and Standing Orders of The Regents.UCOP source - December 15, 1994 memo

May 17, 2007

In a May 16 Calmessages memo to deans, directors, and department chairs, Vice Chancellor for Research Beth Burnside announced a new online briefing program in conflict of interest designed for UC researchers. The text of the memo is included below.On May 23rd, the University of California will launch an online Conflict of Interest Briefing for researchers at all UC locations.

The Briefing, which takes about 30 minutes to complete, is designed to help researchers recognize and deal with conflict of interest situations that may arise during their work. The new Conflict of Interest Briefing was developed by a UC team that included members of the faculty and research staffs from various campuses, headed by the UCOP Office of Research, with a vendor, Workplace Answers. Like the Ethics Briefing, which was rolled out to the campus in April, the Briefing can be taken on any computer with Internet access.

Not all Principal Investigators or those with research responsibilities will be required to take the Briefing. Researchers have been identified as those individuals in the various professorialand research title series who received more than $1000 in salary from selected extramural funding sources over the past 12 months. On May 23rd, the selected Berkeley researchers will receive an email from coibriefing@berkeley.edu with a personalized link that will directthem to the new Conflict of Interest Briefing.

As with the Ethics Briefing, individuals are encouraged to complete the Conflict of Interest Briefing soon after they receive the email notification. The Briefing will remain available to them for their reference throughout the year. Researchers are encouraged to bookmark the link/Briefing so that they may refer to it in the future.

Questions regarding the conflict of interest briefing may be directed to coibriefing@berkeley.edu.

May 09, 2007

The Sponsored Projects Office is recruiting for a Senior Administrative Analyst.

The position will provide the required review and submission of proposals; negotiation of agreements; and all non-financial post-award actions on behalf of the Regents of the University of California and in accordance with federal, state and University regulations and policies. Specifically, as a lead analyst in SPO, the Senior Administrative Analyst is responsible for a wide range of duties including: contract and grant proposal review and submission, negotiation and acceptance of awards, award administration, sponsor relations, professional development, training and mentoring of less experienced staff within SPO and across campus, contract/grant data maintenance, and other related duties as assigned.

May 08, 2007

The Sponsored Projects Office has revised the NASA Access Restrictions Checklist to include a question asking if the project involves one or both of the following special long-term access requirements: federal access to a federally controlled facility, or access to a federal information system for six consecutive months or more.

The National Institutes of Health recently made a variety of changes throughout the eRA Commons system, particularly in the eSNAP function. NIH provides a summary of specific changes in a May 4 NIH Guide announcement. Some key changes are described below.

PIs now have the ability to delegate to any commons-registered individual with an ASST role the ability to view the status of electronically submitted applications. This new menu choice is found in Admin/Account/Delegate Status. Once in the Delegate Status screen, PIs will see a list of all the individuals registered with the ASST role and can manage the ability to “Delegate” and “Remove” delegation for those individuals. Once this delegation has been granted, the individual with the delegated authority will be able to view and access the list of applications associated with the PI. Individuals can have this authority delegated to them by more than one PI. Please note, that the view these delegated individuals now has is equivalent to that of a signing official (SO View) and as such does not include access to confidential information; e.g., summary statements and priority scores. For detailed instructions on how to delegate this authority see eRA Commons Release Notes Version 2.9.2.2.

Person Profile/Reference Letters

For electronically submitted applications that involve separately submitted confidential reference letters (e.g., NIH Director’s Pioneer Award), a feature has been added to electronically monitor the submission of these letters. This monitoring feature appears within the Person Profile where a Reference Letter menu choice now appears. This feature lists only data items appropriate for monitoring the submission of reference letters but does not provide access to the actual documents.

Change in Business Process: Measuring Effort Devoted to Projects

Transitioning to the SF424 Research and Related (R&R) introduced a new business practice for measuring effort devoted to a project—person months. Personnel working on projects now indicate effort by indicating the number of calendar, academic, and/or summer months. To keep a consistent business practice in place for all applications and progress reports, eSNAP has been revised to reflect this new effort measure in two areas: 1) PI Effort, found on the Edit Business/Org Info screen; and, 2) effort for all Key Personnel on the Edit Business/Key Personnel screen. Any edits to the Key Personnel section will require that the user convert annual effort to person months for all Key Personnel listed. Frequently Asked Questions for Person Months and a Conversion Calculator Tool are available at http://grants.nih.gov/grants/policy/person_months_faqs.htm.

The American Chemical Society Petroleum Research Fund (PRF) supports advanced scientific education and fundamental research in the petroleum field. The PRF offers Type AC grants to support new scientific ideas for established scientists and engineers. The PRF has noted that a large percentage of AC proposals are now “continuation” proposals that seek additional funding for extant projects, instead of new, unexplored research projects.

The PRF issued new application forms for Type AC grants on April 30, 2007 and now requires principal investigators to provide a one-page description of what has been done previously in their area of research and then provide a description of how and why the work in the submitted proposal is “new.” Beginning with proposals submitted for consideration at the Winter 2008 PRF Advisory Board meeting, AC proposals that are deemed as ongoing research will be disqualifed.

April 18, 2007

The April 18 Grants.gov Stakeholder webcast included a status update on the transition from PureEdge to the Adobe platform. Grants.gov will continue testing the Adobe platform during April, and release the new 2007 system on May 1. However, the transition will be phased in slowly, with the goal of making the change seamless and simple for both agencies and applicants. The complete transition will be made to the Adobe platform by September 30, the end of FY 2007.

The webcast included a demonstration of the new platform. The steps for applicants are the same as in the current system, and the forms appear approximately the same. Applicants should not have any trouble learning to use the new forms. The only software required is the free Adobe Reader, version 7.0.9.

The Grants.gov staff will be updating the user guides and FAQs soon, and adding a new section to the Grants.gov web site for updates on the transition.

Grants.gov is hosting an “Adobe Day” webcast on May 3 from 11:00 a.m. until noon. Adobe Day will provide information on using Adobe Reader to complete grant applications, show how the new forms will look and act, and discuss changes between PureEdge and Adobe. Check the Grants.gov “What’s New This Week” in the coming days for more information.

The document comprises two previously stand-alone policy documents: the NSF Grant Proposal Guide and the Grant Policy Manual. The new Guide has two sections: the Grant Proposal Guide and the Award and Administration Guide. Each section has a summary of significant changes.

One change is NSF specifies the four fonts that may be used when preparing an NSF proposal. The page formatting section also has been revised to state that a standard, single-column format should be used in the body of the proposal.

Another changes eliminates the previous statutory (one percent) cost-sharing requirement. In accordance with prior Congressional requirements, NSF previously required that each grantee share in the cost of research projects resulting from unsolicited proposals. The appropriations providing funds to NSF no longer contain this language.

April 15, 2007

The Vice Chancellor for Research Office recently modified the Berkeley campus Principal Investigator policy (the Policy On Eligibility For The Submission Of Extramural Support Proposals And Procedures For Obtaining Exceptions). The following changes are in effect as of March 20, 2007:

Detailed definitions have been added to differentiate between Principal Investigator status and Project Director status.

All references to “Program Director” have been deleted (throughout).

Statement governing University employment has been revised to reflect current campus appointment procedures (2.-d.).

The Berkeley campus has reissued the policy on “Cost Principles for Sponsored Agreements (Contracts and Grants).” To accompany the policy, the campus is providing supporting Frequently Asked Questions, and a Quick Guide intended to provide guidance with proposal preparation. In addition, a series of training sessions was offered for department staff and interested faculty.

The policy describes how contract and grant funds must be spent for the campus to be in compliance with applicable state and federal law, and other sponsor terms and conditions. Campus policy is dictated by cost principles contained in Office of Management and Budget (OMB) Circular A-21, which governs our grants, contracts and other agreements with the federal government. For federally sponsored projects, including federal flow-through awards, administrative costs may be charged directly to a sponsored project only under certain specified circumstances. The campus policy and associated materials define administrative and technical costs and provide a framework for determining whether various costs qualify as direct charges to sponsored awards.

The staff of the Controller’s, Extramural Funds Accounting, and Sponsored Projects Offices, and those of Financial and Management Analysis are available to assist investigators and staff with questions.

PRF RevisedThe Sponsored Projects Office Proposal Review Form (PRF) has been revised to include “major project” administrative costs and use of human stem cells. The revised form also has yes/no checkboxes instead of yes and includes web links to related policy and procedure. The PRF instructions have also been updated. Please begin using the revised PRF immediately. The form is available online at http://www.spo.berkeley.edu/forms/UCForms.html#PRF.

Limited Submission Form RevisedThe Limited Submission Cover Sheet has been updated with a new field for other information that might be requested for campus review purposes, depending on agency program requirements. Also, some of the form field names have been changed for clarity. Please use the new form immediately.The form and information on limited submission programs is available at http://www.spo.berkeley.edu/fund/limited.html.

In limited submission programs, the sponsor restricts the number of applications or proposals a campus can submit to the agency. The guidelines for these programs require institutions to screen preproposals or nominations to determine which applications will be submitted for competition. The Cover Sheet is submitted with campus applications.

Non-Federal Team NewsThe Sponsored Projects Office has made some changes to non-federal team assignments. SPO has recruited Deborah Rutkowski-Howard (formerly in Molecular and Cellular Biology), and Roslyn Kartychak is now serving as Proposal Coordinator for the non-federal team.The non-federal team has also recently assigned research administrators by department instead of by sponsor. Nonprofits, private foundations, UC-funded programs, foreign agreements, and other state and local government agreements are assigned by department. State of California agencies are the exception — all State agencies will continue to be handled by Betsy Quayle. Another exception is non-federal limited submission programs, which will be handled by Deborah Rutkowski-Howard.

Please refer to the SPO agency assignment list (http://www.spo.berkeley.edu/Staffnonfederal.html) to locate the research administrator assigned to your unit. If you have questions or concerns about this change, please contact Paula Burkhart, Assistant Director, Non-Federal Projects (pkburkhart@berkeley.edu, 2-8110). SPO believes departmental assignments for these sponsors will serve the campus better and is interested in feedback about the rearrangement of responsibilities.

Federal Team NewsThe SPO federal team now has a department assignment list for NIH and NSF agencies. The list is available at http://www.spo.berkeley.edu/StaffNIHNSF.html. Research administrators are assigned to the most active units. If your department does not have a staff person assigned, you can contact any of the one of the three SPO research administrators for NSF or NIH, or when you submit a proposal it will be assigned to a specific administrator.

New Web Page Lists ERA LinksThe SPO web site has a new page that lists federal, UC, and nonfederal funding agencies and the systems each uses for electronic research administration. The page is available at http://www.spo.berkeley.edu/Procedures/eralinks.html.

SPO Proposal NumberThe Office for the Protection of Human Subjects must have the SPO Proposal Number on the CPHS Cover Sheet for all funding supporting human subjects research when the funding requests have been submitted through the Sponsored Projects Office. Please make sure you list the SPO Proposal Number in the appropriate box under Part III of the Application Cover Sheet if the funding is pending or even if an award has been made.

The SPO Proposal Number is an eight-digit number beginning with the fiscal year (e.g., 20071234) and is available for Coeus web users immediately after proposals are logged in by SPO. The number is included in the proposal notice that is sent by email to investigators and administrative staff after the proposal has been submitted.

Revised Requirements for Continuing Review SubmissionsTo ease the administrative burden on investigators, CPHS/OPHS has changed the submission requirements for applications for Expedited or Full Committee Continuing Review and Approval. Effective immediately, submission of copies of the current, approved protocol narrative will not be necessary under the following specific conditions:

(1) At the time of renewal submission, NO CHANGES are being proposed to the protocol, including personnel or funding changes. The research that will be conducted in the coming year is exactly as described in the current, active approved protocol on file with CPHS/OPHS; and

(2) The current, approved protocol – which includes any amendments that may have been approved and incorporated in the narrative during the past year – must be written in the CPHS narrative format of September 2005 or the most recent version revised in March 2007.

Also, for studies that are moving into a “data analysis-only” phase, investigators will no longer need to submit consent forms, recruitment materials, or a protocol narrative at the time of continuing review, as long as the only change to the approved protocol is that there is no longer any data collection or subject intervention occurring. If the protocol format has not been updated since September 2005, but the study is moving into a data analysis-only phase now, an updated protocol version will not be required. However, if an investigator wishes to collect additional data and/or recruit new subjects, the protocol narrative in the current version as required at that time must be submitted before the protocol amendment will be reviewed and approved.

Submit Protocols EarlyCPHS/OPHS is in the midst of the busiest time of the year as investigators want to get protocols reviewed and approved in time for summer research activities. OPHS strongly advises investigators to submit their projects as soon as possible as all but the full committee protocols are reviewed on a rolling, first-come, first-served basis. Between March and June we are essentially unable to handle “rush” requests due to the huge volume of protocols, so get your protocols in as soon as possible!